Clinical Impact of Cardiac Photon-Counting Detector CT

NCT05240807 | Completed Results FDA Device

• 2 other identifiers: 21-004933R01EB028590
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research trial is to determine whether images taken using a Photon Counting Detector CT scanner (PCD-CT) provide clinically important information about the severity of suspected coronary artery disease and perfusion defects compared to traditional Energy Integrating Detector CT (EID-CT) and nuclear medicine cardiac stress tests.

Conditions

Coronary Artery Disease

Keywords

Coronary CT Angiography; Cardiac Stress Imaging; Photon Counting CT; Cardiac CT

Outcome Measures

Primary Outcomes (2)

• Arm 1: Change in Clinical Coronary Artery Disease Status Measured in Photon-counting Detector CT Relative to Clinical CT as Measured by Percent Area Stenosis

  Percent area stenosis (PAS) measures coronary artery stenosis (blockage) and is defined as the vessel's cross-sectional area in the region of highest stenosis (i.e., most closed) divided by the healthy vessel's cross-sectional area. PAS can range from 0% to 100% with higher percentages indicating worse stenosis. In arm 1, PAS was measured at the site of worst stenosis in each coronary vessel or patient using validated commercial software. For each stenosis, PAS was measured at the same location in the photon-counting detector CT (PCD-CT) angiography scan and in the clinical CT angiography scan (EID-CT). These values were subtracted to get a change in PAS between the clinical EID-CT scan and the PCD-CT scan for each stenosis. Change in PAS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update.

  Through completion of CT exam, approximately 1 hour

• Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting Detector CT at Rest

  Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector (PCD) CT divided by the total number of patients with perfusion defects. Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects. Sensitivity and specificity can range between 0 and 100%. All analyzed images were taken when the patient was at rest.

  Through completion of CT exam, approximately 1 hour

Secondary Outcomes (2)

• Arm 1: Number of Participants With Decrease in Coronary Artery Disease-Reporting and Data System (CADRADS) Score

  Through completion of CT exam, approximately 1 hour

• Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting CT During Cardiac Stress

  Through completion of CT exam, approximately 1 hour

Study Arms (2)

Clinical Coronary CTA Cohort

EXPERIMENTAL

Subjects scheduled for a clinically indicated coronary CT angiogram will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT.

Diagnostic Test: Photon-counting detector computed tomography (PCD-CT)

Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort

EXPERIMENTAL

Subjects scheduled for a clinically indicated nuclear medicine or MRI cardiac stress test will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT at rest and after administration of a cardiac stress agent.

Diagnostic Test: Photon-counting detector computed tomography (PCD-CT)

Interventions

Photon-counting detector computed tomography (PCD-CT) DIAGNOSTIC_TEST

Cardiac CT imaging will be performed using a newly developed CT scanner that uses photon-counting detectors and the results compared to those from conventional CT, MRI, or nuclear medicine imaging systems

Clinical Coronary CTA Cohort; Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for coronary artery cardiac CT imaging or nuclear medicine or MRI cardiac perfusion within the Department of Radiology or Cardiology.
• Patients who are able and willing to sign the informed consent will be enrolled
• Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).

You may not qualify if:

• Patients unable to provide written informed consent
• Pregnancy
• eGFR ≤ 30
• History of prior moderate or severe contrast reaction includes: unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
• Any history of required premedication prior to iodinated contrast administration.
• Patients that consent to participation but do not undergo their clinically-indicated, contrast-enhanced CT, or nuclear medicine or MR perfusion scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).
• Patients experiencing atrial fibrillation, premature ventricular contractions or other heart rhythm abnormalities
• Hospitalized patients or patients under care in the Emergency Department
• Anything by mouth within three hours of the examination
• Known hypersensitivity to Regadenoson, Adenosine, or Dipyridamole.
• Active ongoing wheezing or poorly controlled asthma or COPD (hospitalized within last month or receiving treatment for flair within last month).
• Second (type I or II) or third degree atrioventricular (AV) block or sinus node dysfunction unless patient has functioning artificial pacemaker.
• Ingested greater than 4 oz. of caffeine within the last 12 hours.
• Currently experiencing unstable coronary syndrome.
• Uncontrollable seizures within the last 3 months

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

In arm 1, this study only considers calcified stenosis and makes no claims as to the effect of PCD-CT (versus EID-CT) on non-calcified coronary plaque. Arm 2 recruitment was severely limited because many participants did not want to take a cardiac stress agent. This resulted in a low number of participants in arm 2. Therefore, only descriptive statistics are provided for arm 2.

Results Point of Contact

• Title: Cynthia McCollough
• Organization: Mayo Clinic, Rochester

mccollough.cynthia@mayo.edu

507-284-6875

Study Officials

• Cynthia McCollough, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 15, 2022
• Study Start: August 24, 2022
• Primary Completion: February 19, 2026
• Study Completion: March 19, 2026
• Last Updated: June 12, 2026
• Results First Posted: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)